Associate Director Regulatory Affairs

Codon Partners; United States; On-site; USD 175,000 - 240,000; Full time

Job summary

A biotechnology company is seeking an Associate Director of Regulatory Affairs to lead regulatory strategies and submissions in the United States and Europe. The ideal candidate has 6 to 10 years of experience in Regulatory Affairs within the pharmaceutical or biotechnology sectors and excellent communication skills. Responsibilities include developing global regulatory strategies and preparing submissions to key authorities. This role does not provide sponsorship.

Qualifications

• 6 to 10 years of experience in Regulatory Affairs in pharmaceuticals or biotechnology.
• Experience in regulatory interactions with FDA and EMA.
• Proven track record of authoring INDs and CTAs.

Responsibilities

• Develop and implement global clinical regulatory strategies.
• Lead regulatory strategy and execution for assigned programs.
• Prepare and submit regulatory documents to authorities.

Skills

Clinical regulatory strategy

Regulatory submissions

Communication skills

Attention to detail

Education

Bachelor's degree in a scientific discipline

Advanced degree (MS, PhD, PharmD)

Job description

This range is provided by Codon Partners. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$175,000.00/yr - $240,000.00/yr

Co-Founder and Director - Codon Partners

Associate Director Regulatory Affairs

We are excited to be partnering with a growing biotechnology company advancing novel therapies through late-stage clinical development, is seeking an Associate Director of Regulatory Affairs with a strong background in clinical regulatory strategy across the US and EU.

This individual will serve as a key cross‑functional partner, responsible for leading regulatory strategy and execution for assigned programs, ensuring alignment with global regulatory requirements, and supporting progression through critical clinical and pre‑registration milestones.

Key Responsibilities

• Develop and implement global clinical regulatory strategies to support product development, registration, and lifecycle management.
• Serve as the regulatory lead on cross‑functional project teams, providing strategic input to clinical development plans, study designs, and clinical trial documentation (protocols, IBs, ICFs, etc.).
• Prepare and lead interactions with regulatory authorities (FDA, EMA, MHRA, and other regional agencies), including meeting requests, briefing packages, and follow‑up correspondence.
• Drive the preparation, review, and submission of INDs, CTAs, and amendments, ensuring high‑quality documentation and timely approvals.
• Provide regulatory input on clinical trial labeling, safety reporting, and GCP compliance requirements for global studies.
• Maintain current knowledge of US and EU regulatory frameworks, guidance documents, and trends impacting clinical development and registration.
• Collaborate closely with CMC and Nonclinical Regulatory leads to ensure integrated development and submission strategies.
• Support the preparation of NDA/MAA‑enabling activities, including pre‑submission meetings and regulatory gap assessments.
• Mentor junior regulatory staff and contribute to process improvements and knowledge sharing across the Regulatory Affairs function.

Qualifications

• Bachelor’s degree in a scientific discipline required, advanced degree (MS, PhD, PharmD) preferred.
• 6 to 10 years of progressive experience in Regulatory Affairs within the pharmaceutical or biotechnology industry, including hands‑on clinical regulatory strategy experience.
• Demonstrated experience leading regulatory submissions and interactions with both FDA and EMA.
• Strong understanding of clinical development processes (Phases 1–3) and regulatory requirements across global regions.
• Proven track record of authoring and managing INDs/CTAs and associated amendments.
• Exceptional written and verbal communication skills, with the ability to influence and collaborate across functional teams.
• Strategic thinker with strong attention to detail and the ability to manage multiple priorities in a fast‑paced environment.

Notes

• Sponsorship cannot be provided for this role.
• For more information, please Easy Apply or contact Conner Harman at [e-mail].